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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2007-6000

2. Registrant Information.

Registrant Reference Number: 070051572

Registrant Name (Full Legal Name no abbreviations): Wellmark International

Address: 100 Stone Road West, Suite 111

City: Guelph

Prov / State: Ontario

Country: Canada

Postal Code: N1G 5L3

3. Select the appropriate subform(s) for the incident.

Domestic Animal

4. Date registrant was first informed of the incident.

24-MAY-07

5. Location of incident.

Country: UNITED STATES

Prov / State: GEORGIA

6. Date incident was first observed.

19-MAY-07

Product Description

7. a) Provide the active ingredient and, if available, the registration number and product name (include all tank mixes). If the product is not registered provide a submission number.

Active(s)

PMRA Registration No.       PMRA Submission No.       EPA Registration No. 2724404

Product Name: Zodiac Fleatrol Flea And Tick Spray For Dogs Cats Puppies And Kittens

  • Active Ingredient(s)
    • (S)-METHOPRENE
      • Guarantee/concentration .27 %
    • N-OCTYL BICYCLOHEPTENE DICARBOXIMIDE
      • Guarantee/concentration .62 %
    • PIPERONYL BUTOXIDE
      • Guarantee/concentration .37 %
    • PYRETHRINS
      • Guarantee/concentration .2 %

7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

Unknown

10. Site pesticide was applied to (select all that apply).

Site: Animal / Usage sur un animal domestique

11. Provide any additional information regarding application (how it was applied, amount applied, the size of the area treated etc).

Product was sprayed on dog on May 18, 2007 at about 5 PM local time. No more information available about the rate of application.

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

Yes

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

German Shepherd Dog Mix

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

1

7. Weight (provide a range if necessary )

85

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>24 hrs <=3 days / >24 h <=3 jours

10. Time between exposure and onset of symptoms

>8 hrs <=24 hrs / > 8 h < = 24 h

11. List all symptoms

System

  • General
    • Symptom - Lethargy
  • Nervous and Muscular Systems
    • Symptom - Recumbent
  • Gastrointestinal System
    • Symptom - Vomiting
  • General
    • Symptom - Death

12. How long did the symptoms last?

>24 hrs <=3 days / >24 h <=3 jours

13. Was medical treatment provided? Provide details in question 17.

Unknown

14. a) Was the animal hospitalized?

Unknown

14. b) How long was the animal hospitalized?

15. Outcome of the incident

Not recovered / Non rétabli

16. How was the animal exposed?

Treatment / Traitement

17. Provide any additional details about the incident

(eg. description of the frequency and severity of the symptoms

The product was applied to the dog at 5 PM local time on May 18, 2007. Lethargy was noted the day after application. Approximately 3 hours before death on May 21, 2007, the dog was noted to be laterally recumbent and vomiting. The dog died at 11 AM local time on May 21, 2007. No decontamination or medical treatment is known to have been provided. Necropsy was discussed, but since death occurred three days prior to notification of incident, there would be little benefit from a necropsy.


To be determined by Registrant

18. Severity classification (if there is more than 1 possible classification

Death

19. Provide supplemental information here

The Animal Product Safety Service veterinarian stated on May 24, 2007 in her record after speaking with the owner, "Given signs, area of country, and fact that this dog was not on HW preventative, could certainly have been heartworm disease. Could also have been renal failure from some cause," and "Use of a low concentration flea and tick spray not likely to cause any more than mild bad taste reaction if dog licked some off."